Health TrialsbyHealthPanel

A Clinical Study of SCTC21C in Participants With CD38+ Hematologic Malignancies

ConditionRelapsed or Refractory Hematologic Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSinocelltech Ltd.

About this trial

The purpose of this study is to evaluate the safety and efficacy of SCTC21C in patients with CD38+ hematologic malignancies

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female aged ≥ 18 years old when signing ICF, weight ≥ 40 kg, ≤ 90 kg

Relapsed or refractory CD38+（confirmed by immunohistochemistry or flow cytometry） hematologic malignancies

Standard therapies failed or are unavailable or intolerant

Participants have at least one of the measurable lesions

Disqualifiers

A history of allergic reactions to any SCTC21C injection or any excipients, or Participants with a history of severe drug allergy

Participants who have other antineoplastic drug (except hormones) or radiotherapy within four weeks prior to the first dose of study drug, or the participants who have received immunotherapy or anti-CD38 monoclonal antibody within 6 months

Adverse events from the previous treatment have not resolved to ≤ Grade 1

Participants with prior immunotherapy and Grade ≥ 3 cytokine release syndrome(CRS)

Trial design

Design model

Single group

Treatments tested in this trial

  • SCTC21C

    Biological/Vaccine

    SCTC21C is injected to the participants subcutaneously and is tentatively scheduled to be administered weekly for the first two cycles, once every 2weeks for cycle3-6, and once every 4 weeks thereafter until the occurrence of progressive disease

Treatment groups

74 Participants
are divided into 1 treatment group
Group A: Dose-finding and dose-expansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment-emergent adverse events (TEAEs) and serious adverse event (SAE)

To identify the incidence of TEAEs and SAE

Time frame
From the initiation of the first dose to the 45 days after the last dose
2

The incidence of dose limiting toxicities （dose-finding stage）

To identify the DLTs

Time frame
Cycle 1 (28 days)

Secondary outcomes

1

Objective response rate (ORR)

ORR is defined as the proportion of patients who have an objective remission

Time frame
Throughout the study treatment,an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sinocelltech Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now